Process

• System Analisys (PQLI)
• Process Flow Analisys
• Risk Analisys (GxP/Business)
• Nonconformities structured review and analysis
• Validation Documents wrap up (VP, Protocols, System Description)
• Standard Operating Procedures wrap up
• Test Execution / Supervision
• Audit
• Remediation/Action Plans
• Business Continuity (BS25999)

Validation

• System and Application Software
• Control and Management Systems in pharmaceutical environment (DCS, SCADA, PLC, PID, instrumentation etc.)
• IT Site Infrastructure Network
• Systems/Equipment in Production environment
• Systems/Equipment in Packaging environment
• Systems/Equipment in Laboratory environment
• Building, Utilities e Ancillary
  • HVAC
  • Wharehouse logistic systems
  • Production ancillary systems
  • Water Treatment
• Computerized Systems for analitical Laboratory equipment Management & Control
• Computerized Systems for Clinical Data Management

Technical Qualification

• Commissioning (ISPE vol. 5 march 2001)
• FAT (Factory Acceptance Test)
• SAT (Site Acceptance Test)
• Critical Instrumentation Calibration

Training

• Basic Training & Tailored Courses

Significant work